Clearance Summary
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 received FDA 510(k) clearance under submission number K022934, sponsored by Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2002-11-14.
- Submission: K022934
- Applicant / Sponsor: Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2002-11-14
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.